Why has Medtronic recalled its Sprint Fidelis defibrillator leads?
Medtronic Lead Recall (FAQ): Complete Answers to Your Questi...Medtronic actually refuses to call its actions a recall. Instead, on October 15, 2007, Medtronic issued a "voluntary market suspension" to remove its line of Sprint Fidelis defibrillation leads from the market. Medtronic stated that the leads are prone to fracturing which can cause the defibrillator to deliver unnecessary shocks or not operate at all.
The Sprint Fidelis lead to my defibrillator has not fractured. What should I do?
Medtronic Lead Recall (FAQ): Complete Answers to Your Questi...The FDA recommends that defibrillator settings be adjusted at the patient's next scheduled follow-up visit with their doctor. Doing so may increase the likelihood that a fracture will be detected before a patient is harmed. Unfortunately, no test exists to accurately predict whether a patient's lead will fracture. In some instances, a fractured lead is extracted in the best interest of the patient.
How do I determine if I have a recalled Sprint Fidelis lead?
Medtronic Lead Recall (FAQ): Complete Answers to Your Questi...Check your patient ID or wallet card. If in any of the rows under the column marked Model #, you see one of the following four sets of numbers, 6949, 6948, 6931, or 6930, then you have the recalled heart lead. These numbers may be shown at the beginning of a longer set of numbers and letters on your ID card.
What Sprint Fidelis leads were withdrawn from the market?
The Medtronic Heart Lead Recall: Attorneys For Patients Prov...The Sprint Fidelis leads that have been recalled contain the model numbers 6949, 6948, 6931 and 6930.
I don't have a Medtronic brand defibrillator. Am I therefore unaffected by all of this?
Medtronic Lead Recall (FAQ): Complete Answers to Your Questi...No. The Sprint Fidelis leads were connected to defibrillators made by Medtronic as well as other defibrillator manufacturers such as Guidant and St. Jude, and implanted in or sold to an estimated 268,000 patients worldwide since 2004 -- with roughly 235,000 patients still relying on these implanted leads.
What is the fracture rate for patients with the recalled Medtronic heart lead?
Medtronic Lead Recall (FAQ): Complete Answers to Your Questi...The FDA has stated: "Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. We don't know if this rate of adverse events will remain constant or increase over the life of these leads." The number of injury reports filed with the FDA for the Sprint Fidelis lead, however, have increased with time, suggesting the fracture rate is also increasing.
Should I replace my Medtronic defibrillator or Guidant pacemaker or defibrillator implant?
Guidant Pacemaker Implant, Guidant pacemaker recall: Contak ...You should immediately consult with your physician to determine if your model is part of the recall, if your defibrillator is defective, and whether the risk of surgery is better than the risk of keeping your defective Guidant defibrillator unit.
Which products are being recalled?
Contact Castleberry's BrandsAll of the products on the list. This is a change from the original recall, when only cans with a certain date code were being recalled, so be sure to check your canned food again. We want to remind consumers that as an added level of safety, we are recalling all products listed below, regardless of “Best By” dates printed on the cans.
How can I find out if a product has been recalled?
Household Products Database FAQsAnswer: Visit our new Product Safety and Recall Lists, or contact the Consumer Product Safety Commission (CPSC), Food and Drug Administration (FDA) or the manufacturer of the product.
What's a sprint?
Hill Country Trail Runners - FAQYou get more effect for your time by working the hills, and if you have to rest, then I rest when it is flat... more bang for your buck. During a race, I will only run the downhills and flats, and ease on the uphills. If you plan to run trails, you will eventually run them in the dark. You will eventually learn about flashlights.
Why choose Fidelis?
Fidelis Printmaking – A Division of Fidelis Art Prints...Fidelis is known internationally for it's expertise in capturing every detail in each original, as well as our relentless dedication to truth in colour.
Why is Medtronic legally responsible?
Medtronic Lead Recall (FAQ): Complete Answers to Your Questi...Manufacturers of medical devices have a duty to patients to produce safe products. In lawsuits against Medtronic prepared by Lieff Cabraser, our clients allege that Medtronic misrepresented the safety of the Sprint Fidelis lead. Hundreds of injuries linked to Sprint Fidelis heart defibrillator wires had been reported to the FDA as of the end of 2006. The high and early failure rate of Medtronic Sprint Fidelis leads was also reported in a medical journal in 2006.
What is a Defibrillator?
Thomas Morva - EzineArticles.com Expert AuthorHealth-and-Fitness] A cardiac or heart defibrillator is a device that delivers an electric shock or pulse to the heart in order to alleviate certain disturbances or failures. Typically the goal is to change a fibrillation, or rapid and irregular rhythm, into a slower and steadier beat that can be managed by a care provider.
What is an Automated External Defibrillator (AED)?
AED - Frequently Asked QuestionsAutomated External Defibrillators are specialized medical devices designed to recognize and treat certain lethal heart rhythms in the setting of a cardiac arrest. AEDs deliver an electrical shock to persons in ventricular fibrillation or ventricular tachycardia. AEDs provide auditory and visual prompts to assist first responders in treating a cardiac arrest. AEDs have been shown to decrease mortality when used by trained persons and used in conjunction with cardiopulmonary resuscitation (CPR).
What is a "Sprint"?
Amateur Radio Contesting FAQA sprint is a contest where a station that initiates a QSO (for example, by calling "CQ") must change frequency immediately after the QSO, without working any other station on the same frequency. The reason for this is that in normal contests, high powered and rare stations can get a significant advantage by "running" - calling "CQ" and then working stations one after another on the same frequency, which can result in a very high QSO rate.
Will Vioxx be recalled?
FDA: Vioxx (rofecoxib) Recall Questions and AnswersFDA did not request a recall of Vioxx. This product is being voluntarily withdrawn from the market by Merck.
Why are brands other than Castleberry being recalled?
Clostridium Botulinum Outbreak FAQs | CDC BotulismAll the recalled brands were canned in the same plant. There is concern that other products manufactured at this plant could be contaminated. None of the recalled products should be consumed.
I ate a recalled product. What should I do?
Clostridium Botulinum Outbreak FAQs | CDC BotulismIf you develop signs or symptoms of botulism, seek medical attention immediately. These include new onset of double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, or muscle weakness. If untreated, the illness may progress from head to toe, with paralysis of the face, arms, breathing muscles, trunk, and legs. Symptoms generally begin 18 to 36 hours after eating a contaminated food, but they can occur as early as 6 hours or as late as 10 days.
I have an unopened can of one the recalled products. What should I do?
Clostridium Botulinum Outbreak FAQs | CDC BotulismDo not open or puncture the can. Place the unopened can in a sealable bag, wrap another plastic bag around it, and tape it tightly. Dispose the taped bags in a trash receptacle for non-recyclable trash outside the home and out of reach of humans and pets. Wash hands with soap and running water for at least 2 minutes. Any food that may be contaminated with botulinum toxin should be discarded using extreme care.
